Reported Apr 4, 2018 · Terminated

Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA"…

Covidien LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Lot codes and dates
  • SIGPHANDLE-UDI #10884521543782 Serial#

    2,142 of 2,142 codes

    • C17AAA0001
    • C17AAA0002
    • C17AAA0003
    • C17AAA0004
    • C17AAA0005
    • C17AAA0006
    • C17AAA0007
    • C17AAA0008
    • C17AAA0009
    • C17AAA0010
    • C17AAA0011
    • C17AAA0012
    • C17AAA0013
    • C17AAA0014
    • C17AAA0015
    • C17AAA0017
    • C17AAA0018
    • C17AAA0019
    • C17AAA0020
    • C17AAA0021
    • C17AAA0022
    • C17AAA0023
    • C17AAA0024
    • C17AAA0026
    • C17AAA0027
    • C17AAA0028
    • C17AAA0029
    • C17AAA0030
    • C17AAA0031
    • C17AAA0032
    • C17AAA0033
    • C17AAA0034
    • C17AAA0035
    • C17AAA0036
    • C17AAA0037
    • C17AAA0038
    • C17AAA0039
    • C17AAA0040
    • C17AAA0042
    • C17AAA0043
    • C17AAA0044
    • C17AAA0045
    • C17AAA0046
    • C17AAA0047
    • C17AAA0048
    • C17AAA0049
    • C17AAA0050
    • C17AAA0051
    • C17AAA0052
    • C17AAA0053
    • C17AAA0054
    • C17AAA0055
    • C17AAA0056
    • C17AAA0057
    • C17AAA0058
    • C17AAA0059
    • C17AAB0002
    • C17AAB0003
    • C17AAB0004
    • C17AAB0005
Amount recalled
2121

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Product reportedly shutting down during use.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 14, 2020 · Data as of Sep 19, 5:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.